Concussion Assessments in Football

NCT05713942 | Enrolling By Invitation

• 1 other identifier: 006
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnosing and determining the severity of a sports-related concussion immediately on- or off-field is challenging, especially because clinical signs can evolve minutes to hours after the mechanism of injury. Hence, repeated follow-up and serial assessments of a player are recommended following such an injury. Current advice, when a player sustains a confirmed or suspected concussive injury, is to remove them from play immediately and not return to competition or unrestricted training until signs and symptoms have been managed as per relevant guidelines. To support this decision the International football Association Board has introduced a trial allowing an additional permanent concussion substitution in participating competitions. Follow-up assessment of concussion incidents is recommended to include the Sport Concussion Assessment Tool 5th Edition. For further assessment of neurocognitive deficits and to inform return to play decisions, it is recommended that a computerised assessment is also adopted, such as the Immediate Post-Concussion Assessment and Cognitive Testing tool. The aims of this study are:

1. 1.To determine the incidence of head trauma and use of concussion substitutions in football competitions that are participating in the IFAB's permanent concussion substitution trial.
2. 2.To evaluate the immediate severity of reported concussion signs and symptoms for football players with a confirmed or suspected concussion.
3. 3.To evaluate the ability of neurocognitive assessments completed post-incident to inform the clinical diagnosis of concussion.

Conditions

Cerebral Concussion; Brain Concussion; Post-Concussion Symptoms; TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (1)

• Concussion incident

  Any incident of a suspected or actual concussion occurring in a football match where the permanent concussion substitution was or could have been used.

  January 1st 2021 to August 31st 2023

Secondary Outcomes (2)

• SCAT5 assessment

  Baseline (noninjured), and immediate, +1 day, and +3 days post-concussion incident

• IMPACT assessment

  Baseline (noninjured), and immediate, +3 days, and +6 days post-concussion incident

Interventions

The Sport Concussion Assessment Tool 5th Edition (SCAT5) DIAGNOSTIC_TEST

The SCAT5 is a standardized tool for use by healthcare professionals in the evaluation of individuals 13 years old or older, who are suspected of having sustained a sports-related concussion. It comprises a neuropsychological test battery that assesses attention and memory function through 8 different domains 1) Symptom number, 2) Symptom severity, 3) Orientation, 4) Immediate memory, 5) Concentration, 6) Neurological examination, 7) Balance errors, 8) Delayed recall.

The Immediate Post-Concussion Assessment and Cognitive Testing tool version 4 (ImPACT) DIAGNOSTIC_TEST

The ImPACT is a computer-based neurocognitive test battery that provides an objective measure of neurocognitive functioning as an assessment aid in the management of concussion in individuals ages 12-80 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any football player playing an official match in a competition participating in the IFAB's permanent concussion substitution trial.

You may qualify if:

• Male and female football players from teams in a competition participating in the concussion substitution trial.
• Players with a current suspected or confirmed concussion.
• Player assessed by medical personnel proficient in the assessment of concussion symptoms (medical doctor, physiotherapist, or other healthcare professional appropriately certified).

You may not qualify if:

• \- Players less than 18 years of age.

Sponsors & Collaborators

• Federation Internationale de Football Association: lead
• University of Birmingham: collaborator

Study Sites (1)

University of Birmingham

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Andreas Serner, PhD

  Fédération Internationale de Football Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: January 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)